By Susan Lasser, J.D.
Six cases in one of seven multidistrict litigations concerning transvaginal surgical mesh received mixed rulings by the federal district court in West Virginia presiding over the MDL. Transvaginal surgical mesh manufactured by Boston Scientific Corporation had been used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in the six patients whose cases were addressed by the court on April 1. In one of the cases, similar to the others, the court granted in part and denied in part the manufacturer’s motion for summary judgment (Valencia v. Boston Scientific Corp., April 1, 2016, Goodwin, J.).
In the seven MDLs, there are more than 75,000 cases currently pending, and approximately 19,000 of them are in the Boston Scientific Corp. (BSC) MDL (MDL 2326). The court is conducting pretrial discovery and motions practice on an individual basis to efficiently manage the MDL and ready the cases for trial. To this end, the court ordered the plaintiffs and BSC each to select 50 cases creating a wave of 100 cases. The selection process was completed twice, creating 2 waves. The six cases decided recently were selected as "Wave 1" cases—5 of these cases were chosen by BSC and 1 was chosen by the plaintiffs.
The patient in the current case was chosen by BSC as a Wave 1 case. In February 2009, she was surgically implanted with the Obtryx Transobturator Mid-Urethral Sling System (the Obtryx), a product manufactured by BSC to treat SUI. The patient claimed that as a result of the device being implanted, she has experienced multiple complications. She brought a number of claims against BSC, the manufacturer of the product, including strict liability for design defect, manufacturing defect, and failure to warn; negligence; breach of express and implied warranties; punitive damages; and damages under section 17.50(a)(2) of the Texas Deceptive Trade Practices Act. The court determined that Texas law was applicable in the case.
Statutory defenses/presumptions. The court rejected the manufacturer's argument that Chapter 82 of the Texas Civil Practice and Remedies Code provided two separate statutory presumptions of non-liability that applied to FDA-regulated prescription medical devices, and that both presumptions barred the patient's claims. The first presumption is that the maker is not liable if the manufacturer/seller shows that the product's formula, labeling, or design complied with mandatory safety standards or regulations adopted and promulgated by the federal government, or by a federal government agency. However, the court previously had held that the 510(k) process was not a safety statute or administrative regulation, but rather focused on equivalence. In addition, FDA 510(k) clearance did not "denote official approval of the device," and the FDA prohibits manufacturers of devices cleared through the 510(k) process from making representations that their devices have been approved by the FDA. Thus, the court found this first statutory presumption under Texas law inapplicable because the FDA’s 510(k) clearance process was not a mandatory safety standard or regulation.
Another provision under the state code provides that there is a rebuttable presumption that the product manufacturer or seller is not liable for injuries allegedly caused by the product at issue if the manufacturer/seller establishes that the product was subject to pre-market licensing or approval by the federal government, or a federal agency, that the manufacturer complied with all of the government's/agency’s procedures and requirements with respect to pre-market licensing or approval, and that after consideration of the product’s risks and benefits, the product was approved or licensed for sale by the government or agency. While the FDA conducts a full analysis of a product’s risks and benefits when the product goes through the premarket approval process, this was not the case with the 510(k) clearance process, which relates to a medical device’s equivalence to a preexisting device. Thus, it does not require "full consideration of the product’s risks and benefits." As 510(k) clearance does not constitute FDA "approval" of the device, the state code provision did not apply to BSC in this case.
Design defect. The court denied judgment to the manufacturer on the patient's strict liability design defect claim because it failed to show the absence of a genuine dispute as to any material fact. Texas has adopted the doctrine of strict liability for defective products set forth in section 402A of the Restatement (Second) of Torts. Although the mesh manufacturer argued that comment k to section 402A of the Restatement (Second) barred the patient's design defect claim, the court disagreed. The court explained that comment k exempts certain products from strict liability because they are "unavoidably unsafe," and that the interpretation and treatment of the exemption varies. In states which have found that comment k categorically bars design defect claims for certain medical products, comment k is an absolute bar to design defect claims for particular classes of products. Whether comment k bars a design defect claim is dependent upon the particular product at issue. Other courts have adopted a case-by-case approach. The current court rejected the manufacturer's argument that Texas’s absolute bar for FDA-approved prescription drugs, applied in the case because the Obtryx device was neither FDA-approved nor a prescription drug. Having presented no other argument on design defect, BSC failed to meet its burden under the summary judgment standard.
Failure to warn. Texas follows the learned intermediary doctrine. To prove causation under the doctrine a plaintiff must show that an adequate warning would have changed the decision of the treating physician to use or prescribe the product. Because genuine disputes of material fact existed as to whether BSC’s warning was adequate, and whether the alleged inadequate warning proximately caused the patient's injuries, the court allowed the patient's claim of strict liability for failure to warn to proceed.
Other cases. The court issued similar rulings in five other cases. One (Adams v. Boston Scientific Corp., April 1, 2016, Civil Action No. 2:12-cv-00932, Goodwin, J.), was chosen by the plaintiffs for the first wave of cases, while the others were chosen by the manufacturer (Carroll v. Boston Scientific Corp., April 1, 2016, Civil Action No. 2:13-cv-11601, Goodwin, J.; Craft v. Boston Scientific Corp., April 1, 2016, Civil Action No. 2:12-cv-5898, Goodwin, J.; Fowler v. Boston Scientific Corp., April 1, 2016, Civil Action No. 2:13-cv-03932, Goodwin, J.; and Ramsey v. Boston Scientific Corp., April 1, 2016, Civil Action No. 2:13-cv-15223, Goodwin, J.).
The case is No. 2:13-cv-12330 (MDL 2326).
Attorneys: Ellen A. Presby (Nemeroff Law Firm) for Caroline Valencia and Cheryl A. Carroll. Margaret M. Thompson (Motley Rice LLC) for Jacquelyn Y. Craft. Alex Barlow (Heard Robins Cloud LLP) for Julie Adams and James Adams. Andy Dow Birchfield, Jr. (Beasley, Allen, Crow, Methvin, Portis & Miles, PC) for Judy K. Fowler. Spencer Paul Browne (Reyes Browne Reilley) for Fay Ramsey. A. Bradley Bodamer (Shook, Hardy & Bacon) for Boston Scientific Corp.
Companies: Boston Scientific Corp.
MainStory: TopStory DesignManufacturingNews WarningsNews MedicalDevicesNews DefensesLiabilityNews TexasNews
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